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Singulair, Other Asthma Drugs to Bear Caution on Psychiatric Problems

Jun 15, 2009 | Parker Waichman LLP

Singulair  (montelukast ) and other asthma medications known as leukotriene modifiers will carry a new precaution about their association with neuropsychiatric events, the Food & Drug Administration (FDA) has announced.  According to the agency, it has received reports of agitation, aggression, suicidal thinking, suicide, depression, insomnia and irritability in patients taking leukotriene modifiers like Singulair.

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen.  In addition to Singulair, other leukotriene modifiers include Accolate (zafirlukast)  and Zyflo and Zyflo CR (zileuton).

Singulair and Accolate are  leukotriene receptor antagonists that work by blocking leukotrienes. Zyflo and Zyflo CR are leukotriene synthesis inhibitors which work by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.  All of the drugs are approved to treat asthma, while Singulair is also  approved to treat the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma.

As we reported previously, the FDA had announced in March 2008 that it was reviewing the safety of  Singulair because of reports linking it to neuropsychiatric events, including suicidal behavior. According to a posting on the agency's website, the FDA completed its review in April.  

As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for the medications. According to the FDA,  the post-market reports of patients on  Singulair and similar drugs included cases of neuropsychiatric events.  Some reports included clinical details consistent with a drug-induced effect.
In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed, the FDA said.  However, according to the agency, the available data were limited because the trials were not designed to look for neuropsychiatric events.   Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.


The agency said on Friday that  doctors and their patients should be aware that  mental issues could arise in patients taking leukotriene modifiers and consider discontinuing the drugs if patients develop psychiatric symptoms.  Patients should speak with their doctors if they experience any neuropsychiatric symptoms.

The new information on neuropsychiatric side effects will be included as a precaution in the drugs' prescribing information.  A precaution is a less serious safety notice than a warning.


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